I agree with the above posts that state that clinical trials are necessary even though there are some risks involved with a new investigational drug or device that has not been tried before. Safety measures and precautions must be taken before performing a clinical study to ensure risk is mitigated. A part of the IDE approval process involves evaluating whether or not a device is safe and efficacious. After receiving an IDE a manufacturer must present their clinical study protocol to the IRB. Both of these processes involve stringent reviews to ensure a clinical trial is safe. Additionally, it is critical to have adequate pre-clinical data before testing begins in humans. This includes testing in animals and testing biocompatibility. These measures help to mitigate the risk involved in clinical trials.
Clinical research is significant in determining the safety and effectiveness of medications and medical devices. I agree with the above posts that discussed different aspects and the importance of clinical research on human trials. Undeniably, there is always a possibility of harm to the volunteers who are acting as the subjects for this research. In my opinion, there is a shallow chance of harm to those participants. Extra care is taken to minimize the risks. For example, seventeen federal agencies have regulations governing the conduct of research involving human subjects. Some of them are DHHS, FDA, NSF, and so on.
Clinical studies on humans bring a different perspective on research that cannot be done by animal testing or in vitro testing. If a product is specifically catered for a humans genetics, sometimes the criteria does not get met well if they use mice or rats due to their sizes, life spans, and other factors that influence a rodent but would not necessarily influence a human being. Additionally, having different types of people from different races, ethnicities, sizes, and more could change how a product would work, which cannot be determined by using in vitro or animal studies.
Unfortunately it is never guaranteed to be 100% where it could cause damage to a human long or short term, but its also a risk they are willing to take when participating in a research.
There certainly are advantages and disadvantages to clinical test. An advantage is that we have ways to test if drugs or devices are suitable for sale and public use. A disadvantage is how dangerous some can be as they may require injection or exposure to something that has unknown effects. These test also may come with monetary incentive to encourage participants/ However there are ethic committees and certain laws that help prohibit any extremes and are implemented to protect participants. Overall I feel as though clinical trials are very advantageous and help benefit science.
I think despite clinical studies coming with many risks I think they are necessary. There is only so much we can learn from in vitro and in vivo studies, in order to be certain that a drug will work, we must use clinical studies. I think the drugs or solution be rigorously tested before even considering a clinical trial. That way it mitigates as many risks as possible.
This is a tough one to answer. I feel just like you to an extent. On one hand I know that It’s the best way to understand certain ways to help others. On the other hand, like you said, it’s a life that will be lost if the study goes wrong. However, I think one way to look at it is, without the clinical trial, the life may still be lost as well. I feel if it’s the participant’s idea, and they are fully aware of the potential negative aspects of the trial, then it’s ok. There are some people that he doctors will do anything else for, and they have to essentially sit and wait to pass away. Being apart of a clinical study gives them one last fighting chance. That the advantage to me. Helping save a life is priceless. A disadvantage is the unknown factor. Not knowing if a study will work, and having the lives of others in your hands, can be very hard. But honestly, the good outweighs the bad to me, and as long as it’s the person’s choice, I think it’s a good thing.
I think they are lots of risks and benefits when it comes to human clinical trials. Some of the most noticeable advantages are that it helps further research, a new drug could do less harm to the side as far as side effects, and it can help the people suffering from the ailment. While they're good advantages to human clinical trials I believe they are more disadvantages. These trials can cause harm to the subject, shorten their lifespan, run the risk of the new treatment not working better than a previous one, and have more side effects due to the treatment. With any trial I think you are always going to risk a humans well being.
Recruitment and Retention are a critical part of clinical trials. There can be so many advantages and disadvantages of clinical trials. Some advantages include more access to new treatments, fewer side effects, and multiple tests which gives the patient reassurance. Some disadvantages include treatment is not always effective, patient may experience side effects, treatments may require more hospital stays. All patients should receive all pertinent information and a consent form to acknowledged they understand all potential risks the clinical trial may have before beginning trial.
Clinical studies is very important to the continuous growth of the medical field as a whole.However clinical studies does have its advantages and disadvantages that can be very hard in many aspects.However this studies drive the way for Doctors and researchers to make bigger discoveries with the Medical field.While we are going through this pandemic we see that clinical trail are essential for vaccines and everyday life.
Although there are risks involved in participating and conducting clinical trials, I think there trials are necessary in order to advance in medicine. In my opinion, pros include having access to a drug you need before others, frequent medical care, and the ability to aid others with the work being done. On the other end, its very possible that you can get a placebo in stead of the actual drug, your illness may progress and worsen than when you started, and you may experience some uncomfortable side effects because of the treatment. In the end, no one knows what will happen to them at the end of the trial, and I think its up to the patient to determine whether they want to take that risk.
With clinical studies comes lots of risks, especially where human participants are concerned. However, in order to figure out if a medical product, device, or drug is essential, these studies are necessary. What do you think are the advantages and disadvantages of clinical studies?
I think that clinical studies are necessary for discovery, but I am conflicted when it comes to the risk of the people. If a study goes bad, it can cost the well-being of a person.
Clinical studies are vital to the existence to our current medical world. We are in need of clinical studies and their outcomes. To the brave individuals who volunteer to see how different medical devices, medicines, or therapies work, give others the chance of life saving therapies. The risks involved should not be diminished as there is a huge risk involved in being apart of these studies. But one should ask, do the benefits outweigh the risks? In most cases they really do! If a study is done in an ethical manner and those who have bravely made this sacrifice were well informed of all the possible outcomes, I think that clinical studies truly only have advantages and benefits.
@alexbryant-harden Greetings! I think that your response has prompted me to think a bit further about my response to this question. There are risks involved and in some cases those risks involve the loss of life or other medical complications. I often think about representation in many of these clinical studies. When you spoke about how treatments could work more or less in people, I think that in many clinical studies there isn't an even pool of minorities represented in many clinical studies. Stating the efficacy of a particular treatment, especially medicine, could function quite differently in people of different backgrounds. All of which I think may be a disadvantage of many clinical trials.
With every newfound discovery, there will always be risks associated. Clinical studies provide an opportunity to test their treatments but also assess the patients' response based upon what the drug target claims to manage. Clinical studies provide a more active role for patients to be involved in their healthcare and offers ample opportunities for frequent health checks. Another benefit is having access to treatments before it is available to everyone is the enticing factor for most who are suffering with debilitating diseases. However, clinical trial treatments may not work for everyone and could cause serious side effects. Due to the experimental design of clinical studies, some participants may not be a part of the experimental group and only receive the standard treatment or a placebo. Clinical studies go through trial and error but as of now, it's a path forward to creating and revising drug treatments to meet the needs of the most vulnerable populations.
As with most things in the medical community, clinical trials can pose a risk to the participants because there is no guarantee that everything will go as planned. The pre-clinical trials are established to mitigate as many risks as possible and analyze alternate routes to manipulate the study but again, things do go awry. To fully understand how a device or drug operates with human subjects they will ultimately need to be tested on human subjects. Because there are regulations established and the participants are made aware of the possibilities that could affect them during and after I think the idea of clinical trials should be taken with a grain of salt. The goal is to test on small groups to ensure safety for larger populations and I think most times clinical trials can provide results needed to make this decision or decide if further research should be conducted which is always another alternative.
Clinical research is a great way to test new treatments and see how they effect patients in an ethical manner. Some advantages to clinical studies are that you may be able to access new treatments, there may be fewer side effects compared to standard treatment, you are able to contact a research nurse if you encounter any problems/side effects, and more knowledge on different diseases may become available. Some disadvantages are that the new treatment may not be better than previous ones, there may be more side effects associated with the treatment, and some patients may have to take frequent trips to hospitals to participate in research studies.
